Evaluation of Quality-of-Life Improvements Using UroShield Device

NCT06319352 | Completed FDA Device

• 1 other identifier: HUM00243293
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol. The main questions the investigators aim to answer focus on implementation and practicality:

• Recruitment feasibility and time to recruit
• How well do participants adhere to device protocol?
• How often do device components (i.e., actuators and drivers) have to be replaced?
• How much time is required for data collection and what sources or methods for data collection are used? Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow.

Conditions

Quality of Life; Catheter-Associated Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  Number of patients enrolled out of number of patients eligible to participate in the study.

  Summarized every month for 6 months, or until the recruitment goal is reached.

Secondary Outcomes (3)

• Device use adherence

  Summarized every month for at least 6 months, or until the recruitment goal is reached.

• Device accountability

  Summarized every month for at least 6 months, or until the recruitment goal is reached.

• Efficiency of data collection

  Summarized every month for at least 6 months, or until the recruitment goal is reached.

Study Arms (2)

Active UroShield

EXPERIMENTAL

Active UroShield Device

Device: Active UroShield

Sham UroShield

SHAM COMPARATOR

Inactive UroShield device

Device: Sham UroShield

Interventions

Active UroShield DEVICE

Participants will have an active device (i.e., ultrasound energy is being produced by actuator) attached to their urinary catheter tube.

Active UroShield

Sham UroShield DEVICE

Participants will have an inactive device (i.e., no ultrasound energy being produced by the actuator) attached to their urinary catheter tube. All other aspects of the sham device (look, weight, feel, sound, and operation) are identical to the active device.

Sham UroShield

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18+
• Indwelling urinary catheter (urethral or suprapubic) in place
• Written informed consent (and assent, when applicable) obtained from participant or participant's legal representative
• Able to comply with the requirements of the study

You may not qualify if:

• Pregnant or breastfeeding women
• Antibiotic use in past 10 days
• Ineligible catheter type in place (e.g., antimicrobial coated, 3-way catheter, condom catheter, nephrostomy tube, wicking device)
• Participation in another drug or device study in past 30 days
• History of poor compliance to medical treatment regimens
• Conditions that may severely compromise their ability to complete the study

Sponsors & Collaborators

• University of Michigan: lead
• Nanovibronix: collaborator

Study Sites (1)

Evangelical Home - Saline

Saline, Michigan, 48176, United States

Location

Study Officials

• Lona Mody

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Internal Medicine

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 20, 2024
• Study Start: April 29, 2024
• Primary Completion: October 18, 2024
• Study Completion: November 1, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

US (1)